SHELTON, CONNECTICUT -- Monday, August 5th, 2019 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a leader in developing novel nanomedicines to treat viral diseases, based on the nanoviricdes® platform, announces that its first drug candidate, NV-HHV-101, is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company reports that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.
The in-life stage of the first part of the GLP studies is complete, allowing assessment of clinical observations. The Company is waiting on the full histology studies to assess the effects on all primary organs. The study was conducted by BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies.
The first of these GLP studies, a GLP safety and tolerability study following dermal treatment, was conducted using minipigs, who received twice daily skin treatment for 28 days, at different dosage levels. The animals were evaluated daily for general signs of toxicity including body weight, detailed clinical physical observations as well as the specific evaluation of the skin treatment areas. Topical treatment of the skin at all doses was well tolerated in all animals and all measured parameters remained within normal range in the study.
The Company has previously found that NV-HHV-101 was safe and well tolerated in non-GLP safety/toxicology studies. The GLP studies are an expanded version of the non-GLP studies, with extended treatment, larger number of subjects, and stringent operational requirements as specified by the current Good Laboratory Practices guidelines for such studies.
Additional studies required for the Safety and Toxicology datasets for filing an IND are in progress.
The Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these studies are successful. The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
The GLP Safety/Toxicology studies phase began in June, 2019. The Company produced approximately 1kg of the NV-HHV-101 drug substance under strict quality controlled operations at its cGMP-capable manufacturing facility in Shelton, CT, for these studies.
NanoViricides is a unique company in that it has its own cGMP manufacturing capability for its complex nanomedicine drugs. This has enabled the Company to minimize production time to a safety/tox study quality drug product, as well as to minimize the associated costs. The Company has the capacity and intends to perform cGMP manufacture of its drug candidates as needed for human clinical trials at this facility, allowing rapid progress to clinical trials. We intend to file an IND with the US FDA soon after completion of the GLP Safety/Toxicology studies and receipt of the final reports from the performing agencies.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.